Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV).

Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioGeneric Pharma
• Collaborator: Xiamen Amoytop Biotech Co., Ltd.
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Age > 18 years and < 65 years

• Chronic hepatitis C defined as: HCV antibodies using a third generation test; HCV-RNA positive by PCR; liver biopsy in the past 12 months; METAVIR score of A1 and F0 or higher

• ALT > 1 ULN in the 24 weeks prior to inclusion (W-26; W-2)

• Patients never treated with ribavirin, Interferon or PEG-Interferon

• Normal albumin, prothrombin time > 60%; normal bilirubin

• Alpha-foeto-protein < 3 times the normal range for the laboratory reference

• HBs antigen negative

• Anti Bilharzial antibodies if positive rectal snip shall be done. The examination may be repeated after praziquantel treatment for those with a positive test

• Hemoglobin > 11g/dl, leucocytes > 3000/mm3, neutrophils > 1500/mm3, platelets > 100 000/mm3, blood creatinin < 1.4 mg/dl

• Normal TSH (subjects needing treatment to maintain TSH within a normal range may be included if other eligibility criteria are respected)

• Anti-nuclear antibodies < 1/160

• Fasting blood sugar between 70-115mg/dl ; if glucose intolerance or diabetes, HbA1C < 8.5%

• Normal ophthalmologic examination in patients with history of blood pressure and/or diabetes

• Effective contraception (IUD, diaphragm and spermicide, condoms and spermicides, oral contraceptive, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-provera), tubal ligation, vasectomy) during the treatment period for females. No breastfeeding during the study period

• Signed informed consent

Exclusion criteria

• Other liver diseases associated with chronic hepatitis C: co-infection with hepatitis B (positive HBs antigen); hemochromatosis; alpha-1 anti-trypsin deficiency; Wilson disease; alcoholism-related liver disease; Gilbert disease

• Alcohol intake > 50g/day for males and 40 g/day for females

• Ongoing intravenous drug use

• Aggravated liver cirrhosis: history or presence of ascitis, oesophageal varicosis, liver encephalopathy

• Hepatocellular carcinoma